Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.9 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
180
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
881 mg/m³
Explanation for the modification of the dose descriptor starting point:
No inhalation study available; no systemic toxicity; toxicity based on local effects (irritation)
AF for dose response relationship:
1
Justification:
default value from ECHA-Guidance
AF for differences in duration of exposure:
6
Justification:
default value from ECHA-Guidance
AF for interspecies differences (allometric scaling):
4
Justification:
default value from ECHA-Guidance
AF for other interspecies differences:
2.5
Justification:
default value from ECHA-Guidance
AF for intraspecies differences:
3
Justification:
ECETOC worker default
AF for the quality of the whole database:
1
Justification:
default value from ECHA-Guidance
AF for remaining uncertainties:
1
Justification:
default value from ECHA-Guidance
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Value:
0.3 mg/m³
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
180
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
default value from ECHA-Guidance
AF for differences in duration of exposure:
6
Justification:
default value from ECHA-Guidance
AF for interspecies differences (allometric scaling):
4
Justification:
default value from ECHA-Guidance
AF for other interspecies differences:
2.5
Justification:
default value from ECHA-Guidance
AF for intraspecies differences:
3
Justification:
ECETOC worker default
AF for the quality of the whole database:
1
Justification:
default value from ECHA-Guidance
AF for remaining uncertainties:
1
Justification:
default value from ECHA-Guidance
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.8 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
180
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No repeated dose dermal study available; no systemic toxicity
AF for dose response relationship:
1
Justification:
default value from ECHA-Guidance
AF for differences in duration of exposure:
6
Justification:
default value from ECHA-Guidance
AF for interspecies differences (allometric scaling):
4
Justification:
default value from ECHA-Guidance
AF for other interspecies differences:
2.5
Justification:
default value from ECHA-Guidance
AF for intraspecies differences:
3
Justification:
ECETOC worker default
AF for the quality of the whole database:
1
Justification:
default value from ECHA-Guidance
AF for remaining uncertainties:
1
Justification:
default value from ECHA-Guidance
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
180
Dose descriptor:
other: NOAEL
AF for dose response relationship:
1
Justification:
default value from ECHA-Guidance
AF for differences in duration of exposure:
6
Justification:
default value from ECHA-Guidance
AF for interspecies differences (allometric scaling):
4
Justification:
default value from ECHA-Guidance
AF for other interspecies differences:
2.5
Justification:
default value from ECHA-Guidance
AF for intraspecies differences:
3
Justification:
ECETOC worker default
AF for the quality of the whole database:
1
Justification:
default value from ECHA-Guidance
AF for remaining uncertainties:
1
Justification:
default value from ECHA-Guidance
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

For long term inhalation exposure a systemic DNEL of 4.9 mg/kg bw was derived. Short term systemic effects are covered by this DNEL. Systemic as well as local effects are due to the irritation potential of the material. No other systemic effects were observed.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

The general population is not exposed to the material and no DNEL was therfore derived for this group.